{"id":1040,"date":"2017-02-07T08:22:49","date_gmt":"2017-02-07T08:22:49","guid":{"rendered":"http:\/\/wwwro.anm.ro\/?page_id=1040"},"modified":"2026-02-18T16:33:56","modified_gmt":"2026-02-18T13:33:56","slug":"formulare-si-tarife","status":"publish","type":"page","link":"https:\/\/www.anm.ro\/en\/dispozitive-medicale\/formulare-si-tarife\/","title":{"rendered":"Forms and fees \u2013 Medical Devices"},"content":{"rendered":"

To the attention of economic operators \u2013 taxable persons established in Romania<\/strong><\/span>
\nIn the context of the mandatory implementation of the RO e-Invoice system as of 1 January 2024, according to the provisions of Art. LIX, paragraph (1) of Law 296\/2023, all invoices issued by the NAMMDR, representing tariffs provided for in Order 888\/2014 and Order 3467\/2022, shall be transmitted only through the RO e-Invoice system, regardless of whether or not the recipients are registered into the RO e-Invoice Register.<\/strong><\/span>
\n<\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
Application\/Notification for grant of operation notice on medical device-related activities<\/b>
\ndownload document …<\/a>
\ndownload document …<\/a> <\/td>\n<\/tr>\n
Application for change of operation notice on medical device-related activities<\/b>
\ndownload document …<\/a>
\ndownload document …<\/a> <\/td>\n<\/tr>\n
Application\/Notification for record into the national database of EU\/EEA resident medical device service providers<\/b>
\ndownload document …<\/a>
\ndownload document …<\/a> <\/td>\n<\/tr>\n
Application for grant of notice for use of medical devices<\/b>
\ndescarca documentul …<\/a>
\ndescarca documentul …<\/a> <\/td>\n<\/tr>\n
Application for grant of periodic check bulletin for medical devices<\/b>
\ndownload document …<\/a>
\ndownload document …<\/a> <\/td>\n<\/tr>\n
Application for grant of periodic check bulletin for medical devices in use by mobile intervention units<\/b>
\ndownload document …<\/a>
\ndownload document …<\/a> <\/td>\n<\/tr>\n
Application for grant of notice for use of medical devices in use by mobile intervention units<\/b>
\ndownload document …<\/a>
\ndownload document …<\/a> <\/td>\n<\/tr>\n
Application for grant of notice for use of diagnostic and therapeutic medical devices by ionising radiation, nuclear medicine and MRI<\/strong>
\ndownload document …<\/a>
\ndownload document …<\/a> <\/td>\n<\/tr>\n
Application for grant of periodic check bulletin for diagnostic and therapeutic medical devices by ionising radiation, nuclear medicine and MRI<\/strong>
\ndownload document …<\/a>
\ndownload document …<\/a> <\/td>\n<\/tr>\n
Application for grant of periodic check bulletin for medical devices radioprotection equipment<\/strong>
\ndownload document …<\/a>
\ndownload document …<\/a> <\/td>\n<\/tr>\n
Application for issuance of a customs notice<\/strong>
\ndownload document …<\/a>
\ndownload document …<\/a> <\/td>\n<\/tr>\n
Application for grant of out-of-scope notice<\/strong>
\ndownload document …<\/a>
\ndownload document …<\/a> <\/td>\n<\/tr>\n
Payment form grant of out-of-scope notice \u2013 customs notice<\/strong>
\ndescarca documentul …<\/a>
\ndescarca documentul …<\/a> <\/td>\n<\/tr>\n
Form \u2013 Report on medical device related incidents \u2013 for users<\/strong>
\ndownload document …<\/a>
\ndownload document …<\/a> <\/td>\n<\/tr>\n
Form \u2013 Manufacturer Incident Report (MIR) for Serious Incidents (MDR\/IVDR) and Incidents (AIMDD\/MDD\/IVDD) Reporting Template Version 7.2.1<\/strong>
\ndownload document …<\/a> <\/td>\n<\/tr>\n
Application for clinical investigation<\/strong>
\ndownload document …<\/a>
\ndownload document …<\/a> <\/td>\n<\/tr>\n
Contents of the clinical investigation dossier<\/strong>
\ndownload document …<\/a>
\ndownload document …<\/a> <\/td>\n<\/tr>\n
Application for standard classification of a product, complex classification for a borderline product, classification challenge<\/strong>
\ndownload document …<\/a>
\ndownload document …<\/a> <\/td>\n<\/tr>\n
Application for the issuance of a certificate of free sale of medical devices<\/strong>
\ndownload document …<\/a>
\ndownload document …<\/a> <\/td>\n<\/tr>\n
Application for the issuance of a grant of donation notice<\/strong>
\ndownload document …<\/a> <\/td>\n<\/tr>\n
Application for the issuance of an out of scope notice<\/strong>
\ndownload document …<\/a>
\ndownload document …<\/a> <\/td>\n<\/tr>\n
F.CMD \u2013 Notification form for placing on the market of custom-made devices<\/strong>
\ndownload document …<\/a>
\ndownload document …<\/a> <\/td>\n<\/tr>\n
F.MDIVD_IS \u2013 Notification form for medical devices in vitro diagnostic medical devices manufactured and used within healthcare institutions<\/strong>
\ndownload document …<\/a>
\ndownload document …<\/a> <\/td>\n<\/tr>\n
Fee payment form \u2013 DESIGNATION OR MONITORING OF MEDICAL DEVICE CONFORMITY ASSESSMENT BODY<\/strong>
\ndownload document …<\/a>
\ndownload document …<\/a> <\/td>\n<\/tr>\n
Fee payment form \u2013 EVALUATION OF THE NOTIFICATION FILE OF MEDICAL DEVICES MANUFACTURED AND USED WITHIN PUBLIC OR PRIVATE HEALTHCARE UNITS EVALUATION OF THE NOTIFICATION FILE OF A MODIFICATION<\/strong>
\ndownload document …<\/a>
\ndownload document …<\/a> <\/td>\n<\/tr>\n
Fee payment form – FREE SALE<\/strong>
\ndownload document …<\/a>
\ndownload document …<\/a> <\/td>\n<\/tr>\n
Fee payment form – Issuance of an out-of-scope notice<\/strong>
\ndownload document …<\/a>
\ndownload document …<\/a> <\/td>\n<\/tr>\n
Fee payment form \u2013 ISSUANCE OF CUSTOMS NOTICE<\/strong>
\ndownload document …<\/a>
\ndownload document …<\/a> <\/td>\n<\/tr>\n
Fee payment form \u2013 ISSUE OF AN ORIGINAL DOCUMENT AT THE APPLICANT’S REQUEST<\/strong>
\ndownload document …<\/a>
\ndownload document …<\/a> <\/td>\n<\/tr>\n
Fee payment form \u2013 NATIONAL DATABASE SEARCH FEE<\/strong>
\ndownload document …<\/a>
\ndownload document …<\/a> <\/td>\n<\/tr>\n
Fee payment form \u2013 STANDARD PRODUCT CLASSIFICATION, CLASSIFICATION DISPUTE, (COMPLEX) CLASSIFICATION FOR A BORDERLINE PRODUCT<\/strong>
\ndownload document …<\/a>
\ndownload document …<\/a> <\/td>\n<\/tr>\n
Fee payment form \u2013 Validation_Verification of registration in the European Database on Medical Devices (Eudamed)<\/strong>
\ndownload document …<\/a>
\ndownload document …<\/a> <\/td>\n<\/tr>\n
Fee payment form \u2013 ISSUE OF CERTIFICATE OF REGISTRATION OF MEDICAL DEVICES IN THE NATIONAL DATABASE REGISTRATION OF MODIFICATION OF INFORMATION IN THE DATABASE WITH MEDICAL DEVICES<\/strong>
\ndownload document …<\/a>
\ndownload document …<\/a> <\/td>\n<\/tr>\n
Form F1 \u2013 Notification form for placing medical devices on the market<\/strong>
\ndownload document …<\/a>
\ndownload document …<\/a> <\/td>\n<\/tr>\n
Form F2 \u2013 Notification form for the placing on the market of in vitro diagnostic medical devices<\/strong>
\ndownload document …<\/a>
\ndownload document …<\/a> <\/td>\n<\/tr>\n
Form F3 \u2013 Application form for derogation from conformity assessment procedures<\/strong>
\ndownload document …<\/a>
\ndownload document …<\/a> <\/td>\n<\/tr>\n
Form F3 IVD \u2013 Form for requesting derogation from conformity assessment procedures<\/strong>
\ndownload document …<\/a>
\ndownload document …<\/a> <\/td>\n<\/tr>\n
Form F4 \u2013 Form requesting approval for the exemption of the translation into Romanian of the information provided by the manufacturer together with the medical device<\/strong>
\ndownload document …<\/a>
\ndownload document …<\/a> <\/td>\n<\/tr>\n
Form F4 IVD \u2013 Form requesting an opinion for the exemption of the translation into Romanian of the information provided by the manufacturer together with the in vitro diagnostic medical device<\/strong>
\ndownload document …<\/a>
\ndownload document …<\/a> <\/td>\n<\/tr>\n
Form F5 \u2013 Information form under Article 16 of Regulation (EU) 2017 745<\/strong>
\ndownload document …<\/a>
\ndownload document …<\/a> <\/td>\n<\/tr>\n
Form F5 IVD \u2013 Information form under Article 16 of Regulation (EU) 2017 746<\/strong>
\ndownload document …<\/a>
\ndownload document …<\/a> <\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

To the attention of economic operators \u2013 taxable persons established in Romania In the context of the mandatory implementation of […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":469,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-1040","page","type-page","status-publish","hentry"],"post_mailing_queue_ids":[],"_links":{"self":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages\/1040","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/comments?post=1040"}],"version-history":[{"count":3,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages\/1040\/revisions"}],"predecessor-version":[{"id":10712,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages\/1040\/revisions\/10712"}],"up":[{"embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages\/469"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=1040"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}